NCT03925532

Denosumab in Treating Patients With Bone Loss Due to Donor Stem Cell Transplant

A Phase II Multicenter, Single Arm, Open-Label Trial to Evaluate the Efficacy and Safety of Denosumab in Treatment of Post-Allogenic Hematopoietic Stem Cell Transplant Bone Loss

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This Phase II trial studies the side effects of denosumab and to see how well it works in treating patients with bone loss who have received a donor stem cell transplant. Patients receiving a donor stem cell transplant may experience accelerated bone loss and an increase risk of bone fractures, leading to a decrease in satisfaction and quality of life. A type of immunotherapy drug called denosumab binds to a protein called RANKL, which may help keep bone from breaking down.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the efficacy and safety of denosumab therapy for the treatment of bone loss in patients who have received an allogeneic hematopoietic stem cell transplant. OUTLINE: Patients receive 2 doses of denosumab subcutaneously (SC) between days 70-130 and days 250-310 after allogeneic hematopoietic stem cell transplant in the absence of disease progression or unacceptable toxicity. After completion of study treatment patients are followed up at 6 months.

Conditions

• Allogeneic Hematopoietic Stem Cell Transplantation Recipient
• Osteopenia
• Osteoporosis

Interventions

Type	Name	Description
BIOLOGICAL	Denosumab	Given SC

Timeline

• Start date: 2019-12-19
• Primary completion: 2022-11-16
• Completion: 2022-11-16
• First posted: 2019-04-24
• Last updated: 2024-03-13
• Results posted: 2024-03-13

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study